Neurocrine Biosciences Inc. (NASDAQ: NBIX) announced the publication of expert recommendations for reducing glucocorticoid doses in patients with classic congenital adrenal hyperplasia when treated with CRENESSITY (crinecerfont). The guidelines were published in The Journal of Clinical Endocrinology & Metabolism.

The recommendations consist of two separate manuscripts addressing pediatric patients aged four to 17 years and adult patients. These publications provide the first structured algorithms for adjusting supraphysiologic glucocorticoid dosing after initiating CRENESSITY in clinical practice.

For pediatric patients, the expert recommendations target glucocorticoid reductions toward the upper portion of the physiologic range of 8-11 mg/m²/day in hydrocortisone equivalents, with guidance primarily based on androgen concentrations. For adult patients, reductions are targeted toward the physiologic range of 2-14 mg/m²/day in hydrocortisone equivalents.

"By reducing ACTH and downstream androgen production, CRENESSITY allows patients with classic CAH, including both salt-wasting and simple virilizing forms, to move toward more physiologic, cortisol-replacing glucocorticoid dosing," said Sanjay Keswani, Chief Medical Officer at Neurocrine Biosciences.

CRENESSITY is approved as an adjunct treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic congenital adrenal hyperplasia. The drug received FDA approval in December 2024 based on data from the CAHtalyst Phase 3 studies, which included 285 pediatric and adult patients.

The expert recommendations emphasize that dose reductions should be gradual and clinically supervised, with ongoing assessment for symptoms of glucocorticoid withdrawal and adrenal insufficiency. The guidelines note that glucocorticoid dose reduction is not appropriate for all patients, particularly those already receiving physiologic doses who may use CRENESSITY solely for androgen control.

Information in this article is based on a company press release.